ATO单用或联合ATRA治疗首发急性早幼粒细胞白血病临床对比研究

The comparative study of single-use of ATO or ATO combined with ATRA in the treatment of primary acute promyelocytic leukemia

目的探讨ATO单用或联合ATRA治疗首发急性早幼粒细胞白血病临床疗效及安全性差异。方法选取收治的首发急性早幼粒细胞白血病患者150例,随机分为对照组和联合组,每组75例,分别采用ATO单用和在此基础上与ATRA联用治疗;比较2组患者完全缓解率,完全缓解所需时间,早期死亡率,随访生存率,毒副作用发生率,治疗后肝功能、心肌酶学及血脂指标水平等。结果 2组患者完全缓解率比较差异无统计学意义(P>0.05);联合组患者完全缓解所需时间显著短于对照组,差异有统计学意义(P<0.05);2组患者早期死亡率和随访1年生存率比较差异无统计学意义(P>0.05);联合组患者随访3年生存率显著高于对照组,差异有统计学意义(P<0.05);2组患者药物毒副作用发生率比较差异无统计学意义(P>0.05);联合组患者肝功能指标水平显著高于对照组,差异有统计学意义(P<0.05);联合组患者心肌酶学指标水平显著低于对照组,差异有统计学意义(P<0.05);2组患者治疗后血脂指标水平比较差异无统计学意义(P>0.05)。结论相较于ATO单用,ATO联合ATRA治疗首发急性早幼粒细胞白血病可有效缩短完全缓解所需时间,提高远期生存率,且未增加不良反应发生风险。

Objective To investigate the therapeutic effects and safety of single -use of arsenic trioxide （ ATO） or ATO combined with all -trans retinoic acid （ ATRA） on primary acute promyelocytic leukemia .Methods One hundred and fifty patients with primary acute promyelocytic leukemia who were admitted and treated in our hospital from March 2010 to March 2013 were randomly divided into two groups：control group （ n =75） and combination treatment group （ n =75）.The patients in control group were treated by ATO only , however , the patients in combination treatment group , on the basis of control group,were treated by ATRA.The complete remission rate,the time of reaching complete remission ,early death rate, follow-up survival rate ,incidence rates of toxic and side effects , liver function , levels of myocardial enzymes and blood lipid indexes after treatment were observed and compared between two groups .Results There was no significant difference in complete remission rate between two groups （ P〉0.05）.The time of reaching complete remission in combination treatment group was significant shorter than that in control group （ P〈0.05）.There were no significant differences in early death rates and survival rate after 1-year follow up between two groups （ P〉0.05 ）.The survival rates after 3-year follow up in combination treatment group were significant higher than those in control group （ P〈0.05 ）.There were no significant differences in incidence rates of toxic and side effects between two groups （ P〉0.05）.After treatment the levels of liver function indexes in combination group were significant higher than those in control group （ P〈0.05）.The levels of myocardial enzymes in combination treatment group were significant lower than those in control group （ P〈0.05）.There were no significant differences in the levels of blood lipid indexes between two groups （ P〉0.05）.Conclusion The ATO combined with ATRA in the treatment of primary acute promyelocytic leukemia can effectively shorten the time of reaching complete remission , improve the long-term survival rate , moreover , which does not increase the incidence rate of adverse reactions .